Effects of Accelerated Skill Acquisition Programme With Segmental Vibration on Upper Limb in Stroke.

Not Applicable

Recruiting

• Conditions: Subacute Stroke

• Registration Number: NCT07128823
• Lead Sponsor: Riphah International University

Brief Summary

Stroke is a major health burden and the leading cause of serious long-term disability around the world. One of the most cumbersome deficits after a unilateral stroke is impairment in the contralateral upper limb. Segmental vibration is an intervention that incorporates sensory stimulation to improve motor cortical excitability. This study aims to investigate the influence of a 15-minute SMV application along with accelerated skill acquisition programme (ASAP) on spasticity, motor function, manual dexterity, and somatosensory function of the Upper Limb in Subacute stroke.

This study will be a randomized clinical trial conducted in the physiotherapy department of DHQ Hospital Gujranwala, Gondal Hospital, and Dayan Physiotherapy and Rehabilitation over 10 months. Using the Online Randomizer tool, 60 stroke patients will be recruited through a non-probability convenience sampling technique and randomly divided into two equal groups, Group A and Group B. Group A will receive ASAP with high-frequency segmental vibration(100Hz) on the extensor muscles while Group B, will receive accelerated skill acquisition programme (ASAP) with only. The Assessment tools are the Fugl-Meyer Assessment Scale (for upper limb function), Wolf Motor Functional Test(for motor function), Modified Ashworth Scale(for spasticity), Maximal Hand Grip Strength(for manual dexterity), Nottingham Sensory Assessment(for somatosensory function). Outcome measures will be assessed at baseline,4th week,8th week, and 12th week. Follow-up will be performed in the 16th week. Data analysis will be done by SPSS version 28.0. Two-way Mixed ANOVA, repeated measure ANOVA, and one-way ANOVA will be used in case of normal distribution of data. The Friedman, Kruskal Wallis, and Wilcoxon sign rank tests will be used for non-normal data.

Detailed Description

A stroke is a clinically defined syndrome of rapidly developing symptoms or signs of focal loss of cerebral function with no apparent cause other than that of vascular origin. Still, the loss of function can at times be global (applied to patients in a deep coma and those with subarachnoid hemorrhage. Stroke affects approximately 80.1 million people worldwide and causes 5.5 million deaths annually. The risk of stroke is highest between the ages of 55 and 65. Impaired functional movement in a paretic hand is a common post-stroke challenge. Upper extremity hemiparesis is one of the most common symptoms after stroke. Approximately 55%-75% of stroke survivors suffer from upper extremity moto dysfunction, 40% experience moderate to severe problems in the upper extremity. Which can have a considerable impact on activities of daily living and ultimately lead to a significant reduction in quality of life. The segmental vibrator with (ASAP) Task-Oriented training may have the potential to offer targeted, precise, and adaptable interventions, possibly optimizing the rehabilitation process by reinforcing the neural pathways associated with specific movements, promoting better improvement of motor tasks, their efficacy will aid in providing the rehabilitation strategies that may optimize the upper limb function in sub-acute stroke.

Study Timeline

• Study First Submitted: 2025-04-07
• Study Start: 2025-04-10
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-18
• Last Update Submitted: 2025-08-18
• Study First Posted: 2025-08-19
• Last Update Posted: 2025-08-19
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

The study included participants of both genders(35)

• Participants between the ages of 45 and 65 years.(36)
• Unilateral stroke between 3 months and 6 months post-stroke(32).
• Fugl-Meyer assessment upper extremity (FMA-UE) motor scores between 19 and 58. (32).
• Participants be able to follow the researcher's instructions and study procedures.
• Spasticity of spastic agonist muscles ranging from 0-2 on the modified Ashworth scale(37).
• Montreal Cognitive Assessment (MoCA) score of 24 or higher, indicating sufficient cognitive function to participate in stroke rehabilitation.

Exclusion Criteria

Patients with acute or chronic neurologic or orthopedic impairments and those who experienced discomfort or had undergone surgery in the upper limbs within 6 months before the study onset. (30)

• Pain (FMA-UE pain score of 1 for at least 2 joints) in the affected UE.(32)
• All types of aphasia.(38)
• Visual problems that could not be corrected.(39)
• Individuals with unstable medical conditions that could interfere with rehabilitation progress or pose risks during therapy sessions are typically excluded(40)
• Patients with uncontrolled psychiatric disorders that could compromise their ability to participate in or benefit from rehabilitation are typically excluded(41)
• Metal implants e. g cardiac pacemaker

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment (FMA)	Assessment at baseline, after 4th,8th,12th and 16th weeks	The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess the functioning, balance, sensation, and joint functioning in patients with stroke hemiplegia (0-126 points). Higher scores indicate better motor recovery, with subscores for specific domains like upper extremity (0-66).

Secondary Outcome Measures

Name	Time	Method
Wolf Motor Functional Test (WMFT)	Assessment at baseline, after 4th,8th,12th and 16th week	The Wolf Motor Functional Test (WMFT) measures upper extremity (UE) motor abilities by scoring 15 tasks on performance time and functional ability, with scores ranging from 0 (unable) to 5 (normal). Lower times and higher functional scores indicate better motor recovery.
Modified Ashworth scale (MAS)	Assessment at baseline, after 4th ,8th ,12th and at 16th week.	The Modified Ashworth Scale (MAS) measures spasticity in stroke patients by assessing muscle resistance to passive movement, scored from 0 to 4. A score of 0 indicates no increase in muscle tone, while 4 denotes a rigid limb. It is widely used in stroke rehabilitation to evaluate spasticity in upper or lower limbs. Higher scores correlate with greater spasticity.
Maximal Hand Grip Strength (MHGS)	Assessment at baseline, after 4th ,8th ,12th and at 16th week.	Maximal Hand Grip Strength (MHGS) is a key measure of upper limb function in stroke patients, typically assessed using a dynamometer. In subacute stroke, MHGS scores reflect muscle weakness, with values often ranging from 0-30 kg (compared to 40-50 kg in healthy adults), depending on severity. Lower scores indicate greater impairment, correlating with reduced functional ability in tasks like grasping.
Nottingham Sensory Assessment (NSA)	Assessment at baseline, after 4th,8th,12th and 16th week.	The Nottingham Sensory Assessment (NSA) is a standardized tool to evaluate sensory impairments in stroke patients, focusing on tactile sensation, proprioception, and stereognosis in the upper and lower limbs. It includes 20 items scored on a 3-point scale (0 = absent, 1 = impaired, 2 = normal), with separate testing for affected and unaffected sides. it takes about 15-20 minutes and is reliable for detecting sensory deficits post-stroke.

Trial Locations

Locations (1)

DHQ Hospital Gujranwala, Gondal Hospital, and Dayan Physiotherapy and Rehabilitation; 🇵🇰 Gujrānwāla, Punjab, Pakistan